The European Health Data Space needs to be relevant for paediatric data to support future medicines development for children – a conect4children viewpoint

In April 2024, Members of the European Parliament (MEPs) approved the creation of the European Health Data Space (EHDS). The EHDS aims to improve citizens’ access to and control over their electronic health data for primary (healthcare) and secondary (clinical research) uses. Anticipating the endorsement of the EHDS Regula􀆟on, c4c held a workshop in February 2024 to explore the potential impact of this legislation on paediatric clinical trials. The workshop highlighted that the unique challenges of paediatric data had not been formally considered in the design of the EHDS, particularly when it comes to the provisions in it for the primary use of health data. This paper highlights the collaborations and resources developed and fostered by c4c that aim to address the gaps in paediatric data standards and increase awareness of the need for interoperability. These standards also have a role to improve the care of children as they transition into adulthood as they provide standardized data that can support continuity of care. The collaborations and resources developed over the life of the c4c project will now also play an important role in pushing the paediatric agenda within the EHDS to ensure it does not miss a vital opportunity to accelerate paediatric research and, by extension, rare disease research.